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Osteoarthritis KneePhase 2/3NCT05783154

Effect of Mesenchymal Stem Cells in Primary Knee Osteoarthritis

A Phase 2/3 study testing Autologous Adipose Tissue-Derived Mesenchymal Stem Cell in people with Osteoarthritis Knee, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Osteoarthritis (OA) is the most prevalent chronic joint disorder worldwide and is associated with significant pain and disability. Incidence and prevalence of osteoarthritis rise with increasing age. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Osteoarthritis Knee
What is being tested?
Autologous Adipose Tissue-Derived Mesenchymal Stem Cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteBangladesh
Study dates
16 Sep 2022to 30 Sep 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary osteoarthritis of the target knee refractory to conventional treatment only.
  • Age between 40-70 years.
  • All the genders.
  • Participant with knee pain who fulfill 2016 revised American College of Rheumatology (ACR) criteria for OA knee
  • The Kellgren and Lawrence Grade ≥2 patients.
  • Pain score >3 on Visual analog scale [VAS], (0-10 cm scale).

Who cannot join

  • Previous diagnosis of poly-articular disease
  • Severe mechanical extra-articular deformation (>15° varus/15° valgus)
  • Systemic auto-immune rheumatic disease
  • Arthroscopy or intra-articular infiltration in the last 6 months
  • Chronic treatment with Immunosuppressive or anticoagulant drugs
  • Corticosteroids treatment in the 3 last months
Show all 10Show fewer
  • Non-steroidal anti-inflammatory drugs therapy in the last 15 days
  • Poorly controlled Diabetes mellitus, blood dyscrasias
  • Septic or tubercular arthritis
  • Recent trauma, fracture, and unstable knee joint

Trial locations and contacts

1 site in 1 country.

Moshiur Rahman Khasru, MBBS, FCPS contact

+8801716045646

drkhasrupmr@bsmmu.edu.bd

Bangladesh1 site, 1 recruiting

  • Bangabandhu Sheikh Mujib Medical University

    Dhaka

    Moshiur Rahman Khasru, MBBS, FCPS, +8801716045646, drkhasrupmr@bsmmu.edu.bd

    Moshiur Rahman Khasru, MBBS, FCPS

    Recruiting

Other trials in Bangladesh

About this study

Official title: Effect of Autologous Adipose Tissue-derived Mesenchymal Stem Cells (AT-MSCs) Therapy in Cartilage Regeneration Among Individuals With Primary Knee Osteoarthritis: A Randomized Clinical Trial

Osteoarthritis (OA) is the most prevalent chronic joint disorder worldwide and is associated with significant pain and disability. Incidence and prevalence of osteoarthritis rise with increasing age. The prevalence of OA knee in Bangladesh seems to be higher due to poor working conditions, heavy physical labor, and occupational injuries which increase in the future. This will ultimately create a higher clinical and socioeconomic burden on the population and national economy. The course of the disease varies but is often progressive. OA of the knee is one of the common self-reported musculoskeletal pain conditions causing patients to visit the Physical Medicine and Rehabilitation (PM\&R) department, at BSMMU. The primary objectives of knee OA treatment focus on pain reduction, and joint mobility improvement, as well as the reduction of disease progression and preserving patients' independence and quality of life. Current treatments aim at alleviating these symptoms by several different methods: Non-pharmacological treatments, Pharmacological treatments, and Invasive interventions. Mesenchymal stem cells (MSCs) therapies for knee osteoarthritis are being investigated in various corners of the world. Both positive and negative findings were observed in that research. Although, the effectiveness of MSCs in KOA is not yet well known. Some studies found MSCs effective, and safe in KOA, and it has the potential to regenerate/heal degraded joint cartilage. MSCs can differentiate into cartilage tissue. Furthermore, MSCs have been shown to have paracrine anti-inflammatory and immunomodulatory effects by producing different growth factors and cytokines. This therapeutics option is under investigation to date. The objective of this trial is to find the effectiveness, safety, and dose difference of adipose tissue-derived stem cells (AT-MSCs) therapy for the treatment of knee osteoarthritis (KOA).

But in fact, there is no published data about the effectiveness of autologous adipose tissue-derived mesenchymal stem cells injection on pain, joint functioning, and femoral cartilage thickness in the management of knee osteoarthritis in Bangladesh. Henceforth, this trial will generate new knowledge about the effectiveness, safety, and appropriate dose of AT-MSCs for KOA. So this research will be helpful to generate evidence-based information for an effective treatment option for the management of KOA.

Being tested
Autologous Adipose Tissue-Derived Mesenchymal Stem Cell
Keywords
Osteoarthritis, Pain, Mesenchymal Stem Cell Therapy, Physical function, Outcome, Effectiveness, Disability, Quality of Life
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Adipose Tissue-Derived Mesenchymal Stem CellBiological

    After cleaning the knee with 10% povidone-iodine (Povidep10% solution, manufactured by Jayson Pharmaceuticals limited, Bangladesh) and draping it in a sterile manner, the injection site will be anesthetized with 0.5% bupivacaine (Inj. Bupi Heavy 0.5%, Manufactured by Popular Pharmaceuticals limited, Bangladesh) superficially outside of joint capsule.

    Within one hour of preparation, the autologous AT-MSC will be injected into each knee joint through medial tibio-femoral compartment in group -I using a 38-mm 18- gauge needle

Study groups in NCT05783154
Study groupRoleWhat they receive
Control Group (Group-1)No interventionIn control group: 42 patients with primary KOA will receive standard conventional care including rehabilitation for knee osteoarthritis.
Experimental Group (Group-2)ExperimentalIn the interventional group, another 42 patients with primary KOA will receive adipose tissue-derived mesenchymal stem cells (AT-MSCs) injection intra-articularly (Group-2). However, group-2 (Interventional group) will be subdivided into two sub-groups namely group-2a, and group-2b. A total of 21 Participants of group-2a will receive single doses of autologous adipose tissue-derived stem cell (AT-MSCs) and standard conservative care including rehabilitation for KOA. Whereas, group-2b, 21 respondents will receive two doses of autologous adipose tissue-derived stem cell (AT-MSCs) at 3 months intervals along with standard conservative care including rehabilitation for KOA.
Receives: Biological: Autologous Adipose Tissue-Derived Mesenchymal Stem Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the Articular Cartilage Defect

    Cartilage defect will be evaluated by MRI Osteoarthritis Knee score (MOAKS). MOAKS will be considered to describe the cartilage defect. In MOAKS the knee is divided into 14 articular sub-regions for scoring articular cartilage and Bone Marrow Lesions (BML) [0-100%] where higher score indicates more bone-marrow-lesion and the BML grades are as follows: grade 0= none, grade 1 <33%, grade 2= 33-66% and grade 3 >66%.

    Measured: Cartilage defect will be measure before and after treatment at the month 6 and 12.

  2. Changes in Femoral Cartilage thickness

    Femoral cartilage thickness will be measured at the three level specifically medial condyle, lateral condyle and intercondylar notch using high frequency ultrasound (Machine Model: Chison Qbit-7, Transducer: 15 mega hertz (MHz) Linear). Mean value of the three measurement will be considered for mean femoral cartilage thickness (0-4 mm).

    Measured: Mean femoral cartilage will be measured before and after treatment at the month 6, and12.

  3. Changes in the Pain Intensity

    Pain intensity of the knee joint will be evaluated by visual analogue scale (VAS) ranges between 0 to 10 (0-10 cm scale) where score 0 indicate 'no pain' and 10 indicates 'worst pain'.

    Measured: Pain intensity will be measured before and after treatment at the month 1, 3, 6, and12

  4. Changes in Physical functioning

    Physical functioning will be measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale. WOMAC has 17 item Physical Function measure where each item score ranges between 0 to 4, and total physical function score ranges between 0-68. The higher score indicates worse physical function of the joint examined.

    Measured: Physical functioning will be measured before and after treatment at the month 1, 3, 6, and 12

Secondary outcomes (1)

  1. Any Complications arises

    Any immediate and late complications will be documents up to 12 months after the treatment.

    All the participants will be examined for any complications during each scheduled follow-up at the month 1, 3, 6, and 12 after treatment.

    Moreover, all the participants will be asked to communicate with the investigator team for any complication/issue arises at any time within 12 months of the treatment by dedicated mobile phone number, which will be given to all the participants.

    Measured: At the month 1, 3, 6, and 12 after treatment as well as at anytime within 12 months of the treatment (if required)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2023
  2. Study start16 Sep 2022
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05783154
Sponsor's protocol ID
BSMMU/2022/8897
Status last verified
Mar 2023
First submitted
3 Feb 2023
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It is yet to decide by the research team

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Autologous Adipose Tissue-Derived Mesenchymal Stem Cell in people with Osteoarthritis Knee, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Moshiur Rahman Khasru, MBBS, FCPS (+8801716045646, drkhasrupmr@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the Articular Cartilage Defect (time frame: Cartilage defect will be measure before and after treatment at the month 6 and 12.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05783154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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